XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7

Trials 104

Trials Clinical Trials Clinical Trials Gene Therapy 104

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Gene Therapy Clinical Supply Trials Gene 182

Worldwide Clinical Trials

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

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Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

SEPTEMBER 18, 2023

Experts say a wider diverse pool of patients needs to be given a chance to participate in clinical trials to get rare disease drugs faster to market.

Clinical Trials 162

Clinical Trials Clinical Trials Trials Marketing 162

Bio Pharma Dive

JULY 9, 2021

Zynteglo sales have been on hold since February, when a patient in a clinical trial of another, related Bluebird medicine developed leukemia.

Gene Therapy 274

Gene Therapy Gene Marketing Clinical Trials 274

Bio Pharma Dive

APRIL 18, 2022

Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

Clinical Trials 300

Clinical Trials Clinical Trials Marketing Medicine 300

Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

Clinical Trials 119

Clinical Trials Clinical Trials Trials Marketing 119

Bio Pharma Dive

FEBRUARY 24, 2025

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

Clinical Development 261

Clinical Development Development Clinical Trials Clinical Trials 261

Antidote

SEPTEMBER 25, 2023

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.

Clinical Trials 128

Clinical Trials Clinical Trials Trials Marketing 128

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials 189

Trials Clinical Trials Clinical Trials Drugs 189

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Research Clinical Trials Clinical Trials Immune Response 147

Worldwide Clinical Trials

JANUARY 6, 2025

Through the implementation of full automation in bioanalytical testing PK, immunogenicity, and biomarker assays we streamline trials, reduce costs, save time, and maintain the highest data quality standards. Biomarkers support adaptive trial designs, allowing modifications based on interim results to optimize study outcomes.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Outsourcing Pharma

NOVEMBER 13, 2024

Driven by the effects of the COVID-19 pandemic, the market for decentralized clinical trials has seen a push that will lead it to more than triple in size within the next decade.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Marketing 100

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

Research 130

Research Clinical Trials Clinical Trials Immune Response 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Clinical Trials Clinical Trials Drugs Regulation 243

Pharmaceutical Technology

JULY 29, 2022

According to GlobalData’s Epidemiology and Market Size database, epidemiologists estimate there are more than 21 million prevalent cases within the tracked 16 countries. Last year saw the most with 167 trials. Cerevel Therapeutics has two Phase II/III trials and three Phase III trials planned.

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Trials Drugs Clinical Trials Clinical Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

Trials 188

Trials Clinical Trials Clinical Trials Drugs 188

Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Clinical Trials Compliance 204

Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinical trials to save time and money.

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Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

DECEMBER 6, 2023

The clinical trial market is in a state of flux; to navigate it, supply chain optimisation will be essential.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Marketing 130

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

Clinical Development 341

Clinical Development Clinical Trials Clinical Trials Trials 341

World of DTC Marketing

FEBRUARY 15, 2022

Biotechs need to think like marketers to cut through the noise and attract investors. CEOs have to think like marketers to cut through the clutter with all the biotech startups out there. 2wo: Clinical trial data releases need to coincide with major medical conferences.

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Marketing Clinical Trials Clinical Trials Trials 224

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

Outsourcing Pharma

NOVEMBER 13, 2024

Driven by the effects of the COVID-19 pandemic, the market for decentralized clinical trials has seen a push that will lead it to more than triple in size within the next decade.

Clinical Trials 92

Clinical Trials Clinical Trials Marketing Trials 92

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

Pharmaceutical Technology

APRIL 13, 2023

Takeda’s announcement underlines the risk associated with gene therapy R&D at the preclinical stage and the fact that many current AAV programs are unlikely to reach late-stage trials.

Gene Therapy 243

Gene Therapy Marketing Gene In-Vivo 243

Pharmaceutical Technology

MARCH 28, 2023

lower than the previous market day’s close. In December 2022, BioNTech initiated a Phase I clinical trial of BNT163 – an HSV vaccine candidate. In the same month, BioNTech also initiated a Phase I clinical trial (NCT05581641) of the multi-antigen malaria vaccine BNT165b1— the first candidate from the company’s BNT165 program.

Vaccination 276

Vaccination Vaccine Development Clinical Trials 276

Cloudbyz

JUNE 9, 2024

In the realm of clinical trials, particularly in oncology and rare disease research, SDOH play a pivotal role in shaping patient participation, adherence, and overall outcomes. Integrating eClinical systems can help mitigate these disparities, enhancing the inclusivity and efficacy of clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 103

Pharmaceutical Technology

JANUARY 6, 2023

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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Clinical Trials Clinical Trials Trials Development 289

Velocity Clinical Research

OCTOBER 21, 2024

It was our third time receiving the award, which recognizes the fastest-growing mid-market businesses in the state. For a clinical trials organization to achieve this level of scale is notable. Recruitment Clinical trial sites live and die by their ability to recruit patients into trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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Trials Clinical Trials Clinical Trials Production 59

Cloudbyz

AUGUST 30, 2024

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

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Compliance Clinical Trials Clinical Trials Trials 93

Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Along with the patent-related changes, the EC is seeking to ease some of the regulatory steps.

Marketing 264

Marketing Medicine Production Clinical Trials 264

Outsourcing Pharma

JUNE 13, 2024

To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

Pharmaceutical Technology

SEPTEMBER 22, 2022

Your healthcare practitioner can access the sequencing results, and artificial intelligence (AI) and quantum computing will analyse these records and support the practitioner in making future clinical decisions. It could be that you are lucky, and there is already a cancer vaccine on the market that you will get priority for.

Genome 342

Genome Genomics Clinical Trials Clinical Trials 342

Pharmaceutical Technology

MARCH 28, 2024

Boundless has two assets in clinical trials targeting extrachromosomal DNA in cancer patients.

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DNA Clinical Trials Clinical Trials Marketing 147